EUCTR2010-018712-32-GB
Active, not recruiting
Not Applicable
A Pilot Pharmacodynamic/Pharmacokinetic Study of SalmeterolXinofoate as a Dry Powder in Combination with Fluticasone in Patients with Asthma for Dose-Scale Bronchodilator Model Development.
DrugsAdvair Diskus 100/50
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Oriel Therapeutics Inc
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult males and females \= 18 years with BMI 19 to 32 kg/m2 (inclusive) and a bodyweight \= 50 kg.
- •2\. Patients with a clinical diagnosis of mild to moderate asthma (defined as satisfying
- •the Global Initiative in Asthma \[GINA] definition of asthma or has satisfied in the
- •past and have a pre\-bronchodilator forced expiratory volume in 1 second (FEV1\)
- •\>50% at Screening.
- •3\. Patients must demonstrate \= 15% reversibility (and a \= 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 400 mcg salbutamol by MDI with spacer or up to 5 mg salbutamol by nebulizer at Screening.
- •4\. Patients who if female, are not currently pregnant or breast feeding and are using
- •medically acceptable methods of contraception.
- •5\. Patients whose clinical laboratory test results are not clinically relevant and are
- •acceptable to the Investigator.
Exclusion Criteria
- •1\. Patients who do not conform to the above inclusion criteria.
- •2\. Patients who have a clinically relevant history or presence gastrointestinal, renal,
- •hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric,
- •musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders which would preclude participation in the opinion of the
- •Investigator.
- •3\. Patients who have a clinically relevant medical or surgical history that would preclude the administration of inhaled corticosteroids as indicated in the patient information leaflet for Seretide Accuhaler or Advair® Diskus®.
- •4\. Patients who have a QTc of \> 500 msec.
- •5\. Patients who have a history of relevant drug hypersensitivity.
- •6\. Patients who have a history of alcoholism.
- •7\. Patients who have a history of drug abuse.
Outcomes
Primary Outcomes
Not specified
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